Novartis' omalizumab on track for filing in serious skin disease

Is active ingredient in asthma drug Xolair

New data from a phase III trial will allow Novartis to file for approval of omalizumab - the active ingredient in its asthma drug Xolair - in a severe skin disease called CSU by the end of the year.

CSU (chronic spontaneous urticaria) is a chronic condition characterised by red, swollen, itchy and sometimes painful hives or wheals on the skin that can occur without warning and last for weeks on end.

At present there is no approved treatment for the debilitating disease other than antihistamines, and these drugs only work in around half of patients and sometimes have to be given in very high doses. CSU occurs in around 0.5 to 1 per cent of the world's population.

Novartis has just reported data from the pivotal GLACIAL trial of omalizumab in CSU (also known as chronic idiopathic urticaria or CIA) which indicate the drug given as a once-monthly subcutaneous injection was effective in treating around 40 per cent of patients who do not respond to antihistamines.

A third of the antihistamine non-responders were itch- and hive-free after 12 weeks on omalizumab, which acts by blocking the activity of immunoglobulin E (IgE), a key mediator in the inflammatory response.

That tally remains somewhat shy of earlier predictions for the drug in asthma - which had run as high as $3bn at peak - mainly because it is reserved for use only in patients over 12 with severe allergic forms of the disease. Also efforts to reduce the eligibility age to six were rejected by the US FDA in 2009 on safety grounds, with the agency citing possible elevated cardiovascular risk, although that indication was approved in Europe.

The drug carries a high price relative to other asthma drugs, at around $500 to $2,000 per month depending on dose, which may also be a factor in its lower-than-expected take-up. Novartis has been rolling out a new pre-filled syringe formulation of Xolair to try to drive sales, and approval in CSU could add another string to Xolair's bow.